(172 days)
TD-1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
The Digital Thermometer TD-1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with a disposable probe cover when taking temperature.
From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
Here's a breakdown of the acceptance criteria and study information for the Digital Thermometer, model TD-1001, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard Complied | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|---|
| Display temperature range | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Laboratory accuracy | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Operating range | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Storage environment test | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Shock test | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Water resistant test | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Cleaning procedure test | ASTM E1112-00:2011 | Met requirements of standard | Measurement error (details not provided in summary) |
| Software validation | ISO 14971:2007 | Met requirements of standard | Verification and validation of TD-1001 software (details not provided) |
| Clinical accuracy | prEN12470-3:2000 | Met requirements of standard | Clinical bias, Clinical repeatability (details not provided) |
| Safety | IEC 60601-1 | Met requirements of standard | Evaluated by SGS (details not provided) |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2 | Met requirements of standard | Evaluated by SGS (details not provided) |
Note: The provided summary states that the device "met the requirements" of the specified standards. It does not explicitly list numerical acceptance criteria or the precise numerical performance results for each test within this summary document. For a full understanding of the acceptance criteria and detailed performance, one would need to refer to the full study reports and the standards themselves (ASTM E1112-00:2011, prEN12470-3:2000, ISO 14971:2007, IEC 60601-1, IEC 60601-1-2).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary text.
- Data Provenance: Not specified in the provided summary text. The manufacturer is based in Taiwan, but the location of the testing is not mentioned. It is implicitly a prospective study, as it's a test of a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the summary. For a digital thermometer, "ground truth" for clinical accuracy would typically involve comparison against a highly accurate reference thermometer, not necessarily expert consensus.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where human interpretation is involved (e.g., medical imaging). For a digital thermometer, the tests mentioned are objective performance comparisons against established measurement standards. Therefore, an adjudication method in this sense is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to measure the improvement in human reader performance with AI assistance. A digital thermometer is a direct measurement device and does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Yes, a standalone performance study was implicitly done. The listed tests (e.g., laboratory accuracy, clinical accuracy) directly assess the performance of the device itself (the "algorithm only," in a broad sense, meaning the device's measurement capability) against established standards, without requiring a human to interpret the device's output beyond reading the display.
7. Type of Ground Truth Used
- The ground truth for most performance tests (e.g., laboratory accuracy, display temperature range, operating range) would be measurement against a calibrated reference thermometer as defined by the standards (ASTM E1112-00:2011, prEN12470-3:2000). For clinical accuracy, this would involve comparing the device's readings with a reference method in human subjects.
8. Sample Size for the Training Set
- Not applicable. The TD-1001 is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set" in the conventional sense. Its "training" is in its design and calibration processes, not through data-driven learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.